StrokeNCT06447649
Investigation of Factors Affecting Shoulder Pain in Stroke Survivors
An observational study of Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 28 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients treated in the Physical Therapy and Rehabilitation Unit of Pamukkale University Faculty of Medicine Hospital. We conducted patient selection through screening using the Probel system, and randomly assigned patients who met the inclusion criteria and agreed to participate in the study using a random number table.
Who may be able to join
- having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA)
- having experienced a first-time stroke
- having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage
- not having any other neurological/orthopedic problems in addition to hemiplegia
- not having any shoulder problems on the same side (affected side) before the stroke
- not having any shoulder problems on the same side (affected side) before the stroke
Who cannot join
- having a history of shoulder injury (affected side)
- neurological and orthopedic diseases other than stroke
- prior stroke
- bilateral involvement
- non-cooperation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain
Read the detailed description
The study included 62 stroke patients who got stage 3 or more from the Brunnstrom upper limp stage. We assessed shoulder pain using the Visual Analog Scale, evaluated muscle tone using the Modified Ashworth Scale, identified myofascial trigger points by manual palpation, and measured range of motion using a universal goniometer. We employed the Fugl-Meyer Upper Extremity Assessment to assess the functional status of the upper extremities. We also used the Neer Impingement, Apprehension, Acromioclavicular Shear, and Speed Tests to evaluate the soft tissue condition.
- Conditions
- Stroke
- Keywords
- Functionality, Hemiplegic Shoulder Pain, Stroke, Muscle Tone, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | We included stroke patients aged between 20 and 85. inclusion criteria for this study; having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA), having experienced a first-time stroke, having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage, not having any other neurological/orthopedic problems in addition to hemiplegia, not having any shoulder problems on the same side (affected side) before the stroke, scoring 25 or above on the Mini Mental Test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) used to asses shoulder pain of stroke survivors. The patient will be asked to indicate the point on a 10 cm line that best represents their pain, with 0 indicating no pain and 10 indicating unbearable pain. Subsequently, the distance of the point from the 0 point will be measured using a ruler to determine the intensity of the pain. Following this, the patient will be inquired about the localization and type of pain.
Measured: 1 year
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) used to evaluated of muscle tone. A scale commonly used for spasticity assessment in clinical settings. The initial form, known as the Ashworth Scale, categorizes the resistance of the extremity to passive movement within a range of 0-4 points. Subsequently, the scale includes a value of 1+, defining it as the 6-point Modified Ashworth Scale. (9) According to MAS
Measured: 1 year
Fugl Meyer Motor Assesment Scale (FMMAS)
Fugl Meyer Motor Assesment Scale (FMMAS) was employed to evaluate motor recovery after a stroke, it is a disease-specific, reliable, and up-to-date scale. It includes sub-sections assessing joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score achievable from the upper extremity assessment is 66,
Measured: 1 year
Neer Impingement Test
Neer Impingement Test was used to identify possible subacromial impingement syndrome. The patient's shoulder is passively brought into flexion and internal rotation position. The positive examination finding is the occurrence of shoulder pain during the movement of the arm in this position. The test has a sensitivity of 68% and a specificity of 68.7%.
Measured: 1 year
Speed Test
Speed Test was used to identify possible biceps tendon pathologies. When shoulder flexion is performed against resistance with the elbow extended and the forearm supinated, the presence of pain in the bicipital groove indicates a positive test.
Measured: 1 year
Acromioclavicular Shear Test
Acromioclavicular Shear Test was used to identify acromioclavicular joint pathology. The examiner cups their hands over the shoulder with the heel of one hand on the clavicle, and the heel of the other on the spine of the scapula, and then squeeze their hands together. A positive result is abnormal movement or pain at the acromioclavicular joint. The test has a sensitivity of 100% and a specificity of 97%
Measured: 1 year
Apprehension Test
Apprehension Test was used to detect the presence of anterior instability. As the shoulder is passively moved into maximum external rotation in abduction, and forward pressure is applied to the posterior aspect of the humeral head. If the patient expresses concern about dislocation or reports pain in the shoulder, the test is considered positive. The test has a sensitivity of 58% and a specificity of 96%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Dec 2019
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre BASKAN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447649
- Sponsor's protocol ID
- PAU-FTR-CA-01
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Affecting Shoulder Pain in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06447649
- Acronym / sponsor ID
- PAU-FTR-CA-01
- Conditions
- Stroke
- Keywords
- Functionality, Hemiplegic Shoulder Pain, Stroke, Muscle Tone, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain
Detailed description
The study included 62 stroke patients who got stage 3 or more from the Brunnstrom upper limp stage. We assessed shoulder pain using the Visual Analog Scale, evaluated muscle tone using the Modified Ashworth Scale, identified myofascial trigger points by manual palpation, and measured range of motion using a universal goniometer. We employed the Fugl-Meyer Upper Extremity Assessment to assess the functional status of the upper extremities. We also used the Neer Impingement, Apprehension, Acromioclavicular Shear, and Speed Tests to evaluate the soft tissue condition.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –We included stroke patients aged between 20 and 85. inclusion criteria for this study; having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA), having experienced a first-time stroke, having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage, not having any other neurological/orthopedic problems in addition to hemiplegia, not having any shoulder problems on the same side (affected side) before the stroke, scoring 25 or above on the Mini Mental Test. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients treated in the Physical Therapy and Rehabilitation Unit of Pamukkale University Faculty of Medicine Hospital. We conducted patient selection through screening using the Probel system, and randomly assigned patients who met the inclusion criteria and agreed to participate in the study using a random number table.
Key inclusion criteria (6 listed)
- having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA)
- having experienced a first-time stroke
- having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage
- not having any other neurological/orthopedic problems in addition to hemiplegia
- not having any shoulder problems on the same side (affected side) before the stroke
Key exclusion criteria (5 listed)
- having a history of shoulder injury (affected side)
- neurological and orthopedic diseases other than stroke
- prior stroke
- bilateral involvement
- non-cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale (VAS)
Time frame: 1 year
Visual Analog Scale (VAS) used to asses shoulder pain of stroke survivors. The patient will be asked to indicate the point on a 10 cm line that best represents their pain, with 0 indicating no pain and 10 indicating unbearable pain. Subsequently, the distance of the point from the 0 point will be measured using a ruler to determine the intensity of the pain. Following this, the patient will be inquired about the localization and type of pain.
Modified Ashworth Scale (MAS)
Time frame: 1 year
Modified Ashworth Scale (MAS) used to evaluated of muscle tone. A scale commonly used for spasticity assessment in clinical settings. The initial form, known as the Ashworth Scale, categorizes the resistance of the extremity to passive movement within a range of 0-4 points. Subsequently, the scale includes a value of 1+, defining it as the 6-point Modified Ashworth Scale. (9) According to MAS
Fugl Meyer Motor Assesment Scale (FMMAS)
Time frame: 1 year
Fugl Meyer Motor Assesment Scale (FMMAS) was employed to evaluate motor recovery after a stroke, it is a disease-specific, reliable, and up-to-date scale. It includes sub-sections assessing joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score achievable from the upper extremity assessment is 66,
Neer Impingement Test
Time frame: 1 year
Neer Impingement Test was used to identify possible subacromial impingement syndrome. The patient's shoulder is passively brought into flexion and internal rotation position. The positive examination finding is the occurrence of shoulder pain during the movement of the arm in this position. The test has a sensitivity of 68% and a specificity of 68.7%.
Speed Test
Time frame: 1 year
Speed Test was used to identify possible biceps tendon pathologies. When shoulder flexion is performed against resistance with the elbow extended and the forearm supinated, the presence of pain in the bicipital groove indicates a positive test.
Acromioclavicular Shear Test
Time frame: 1 year
Acromioclavicular Shear Test was used to identify acromioclavicular joint pathology. The examiner cups their hands over the shoulder with the heel of one hand on the clavicle, and the heel of the other on the spine of the scapula, and then squeeze their hands together. A positive result is abnormal movement or pain at the acromioclavicular joint. The test has a sensitivity of 100% and a specificity of 97%
Apprehension Test
Time frame: 1 year
Apprehension Test was used to detect the presence of anterior instability. As the shoulder is passively moved into maximum external rotation in abduction, and forward pressure is applied to the posterior aspect of the humeral head. If the patient expresses concern about dislocation or reports pain in the shoulder, the test is considered positive. The test has a sensitivity of 58% and a specificity of 96%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.